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AzTrials

IVFNCT04044599

Lactobacillus for Luteal Phase Support

A study testing Gynoflor in people with IVF, run by Uludag University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of this study was to evaluate the effect of vaginal lactobacilli, a regulator of normal vaginal flora, on embryo implantation success during IVF / ICSI cycle follow-up. Read more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
IVF
What is being tested?
Gynoflor
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteTurkey (Türkiye)
Study dates
30 Mar 2020to 1 Jun 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • having embryo transfer of a day 5 good quality embryo

Who cannot join

  • Uterin pathologies
  • Having additional adjuvants for luteal phase support
  • Having day 3 embryo transfer

Trial locations and contacts

1 site in 1 country.

Gurkan UNCU, Prof. contact

02242952541

guncu@gurkanuncu.org

Isil Kasapoglu, Specialist contact

02242952542

kasapogluisil@hotmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Uludag University ART Center

    Bursa

    Gürkan Uncu, Prof., 02242952541, guncu@gurkanuncu.org

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Lactobacillus for Luteal Phase Support to Improve IVF Outcomes

The aim of this study was to evaluate the effect of vaginal lactobacilli, a regulator of normal vaginal flora, on embryo implantation success during IVF / ICSI cycle follow-up.

Read the detailed description

Urogenital region accounts for 9% of the total human microbiome. The role of vaginal microbioma in infertility and assisted reproductive technologies has not yet been clarified. It is thought that microorganisms such as mycoplasma, chlamydia and Neiseria gonorrhea are associated with infertility, and changes in subclinical microbiota such as bacterial vaginosis (BV) may be a risk factor for subfertility. The majority of the normal elements of the vaginal flora are the various Lactobacillus species. Lactobacilli constitute a healthy environment for the embryo in the pre- and peri-conception period. They are thought to support implantation not only by their presence but also by the lactic acid, hydrogen peroxide, bacteriocin and probiotics they produce. Bacterial vaginosis (BV) is the reduction of lactobacilli in the dominance of the vaginal microbiota and the transition of the microbial environment to the dominance of Gardnella vaginalis.The two main functions of lactobacilli in translating the balances in the reproductive system in favor of successful implantation and pregnancy rates; lactic acid production and H 2 O 2 recovery. It has been shown that up to 40% of patients undergoing in vitro fertilization (IVF) cycles have abnormal reproductive tract microbiata. To date, studies on vaginal microbiata and implantation have been carried out to identify vaginal microbiome by genetic sequencing of the vaginal specimens. In these studies, endometrial microbiota; When lactobacilli were classified as dominant (> 90%) and non-lactobacilli were dominant; In the presence of lactobacilli non-dominant microbiota, decreased implantation, pregnancy and ongoing pregnancy rates and more negative reproductive results were obtained.

To date, the limited number of studies evaluating the effects of lactobacilli on assisted reproductive methods success and implantation; vaginal or endometrial lactobacilli burden was evaluated. Therefore, for the first time in our study; The aim of this study was to evaluate the effect of vaginal lactobacilli, a regulator of normal vaginal flora, on embryo implantation success during IVF / ICSI cycle follow-up.The study group will be composed of patients who will receive 4 vaginal lactobacillus tablet immediately after the OPU procedure.The ones who will not receive vaginal lactobacillus tablets will compose the control group.

Patients will be selected from infertile patients that underwent IVF/ICSI protocol. There will be no change in the routine ovarian stimulation protocols and luteal phase support treatments that patients should receive routinely. Following ovulation induction with controlled ovarian stimulation (KOH), which is routinely administered in IVF treatment cycles, following the collection of oocytes, the luteal phase support is routinely recommended for the preparation of the endometrium to embryo transfer in artificial, stimulated cycles on the evening of the same day. If pregnancy occurs, luteal phase support should be continued for an average of 8 weeks. In fresh embryo transfer cycles, vaginal progesterone is routinely used for luteal phase support in all patients in our clinic. All patients will receive the same luteal phase treatment routinely.For the study the patients who will have day 5 good quality embryo transfer performed will be selected.

Conditions
IVF
Being tested
Gynoflor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GynoflorDrug

    VAGİNAL GYNOFLOR

Study groups in NCT04044599
Study groupRoleWhat they receive
StudyExperimentalTHE GROUP THAT WİLL RECİEVE VAGİNAL LACTOBACİLLUS
Receives: Drug: Gynoflor
ControlNo interventionControl group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Implantation rate

    To see the gestational sac

    Measured: 4 weeks after embryo transfer

Secondary outcomes (1)
  1. clinical pregnancy

    To see the fetal cardiac activity

    Measured: 6 weeks after embryo transfer

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2019
  2. Study start30 Mar 2020 (estimated)
  3. Primary completion1 Jun 2020 (estimated)
  4. Study completion1 Jun 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04044599
Sponsor's protocol ID
2019-11/24
Status last verified
Mar 2020
First submitted
1 Aug 2019
Last updated
24 Mar 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Gynoflor in people with IVF, run by Uludag University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Gurkan UNCU, Prof. (02242952541, guncu@gurkanuncu.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Implantation rate (time frame: 4 weeks after embryo transfer). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020.

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Lactobacillus for Luteal Phase Support (NCT04044599) | AzTrials